Study to Allow Access to Pasireotide for Patients Benefiting From Pasireotide Treatment in Novartis-sponsored Studies

NCT ID: NCT01794793

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 337 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-10
• Study Completion Date: 2023-07-25

Brief Summary

The purpose of this study is to allow continued use of pasireotide in patients who are on pasireotide treatment in a Novartis-sponsored study and are benefiting from the treatment as judged by the investigator.

Detailed Description

This is a multi-center, open label, phase IV study to provide continued supply of pasireotide to patients being treated in a current Novartis-sponsored study and who are benefiting from treatment with pasireotide alone or in combination with another treatment for Cushing's Disease and Acromegaly . Eligible patients are to be consented and can then continue treatment with pasireotide alone or in combination with another treatment for Cushing's Disease and Acromegaly in this protocol. All patients at their scheduled visits will have drug dispensing information and reported adverse events and serious adverse events collected.

A patient will reach the end of study when pasireotide treatment is permanently discontinued and the end of treatment visit has been performed. All patients must be followed up for safety evaluations for 3 months following the last dose of pasireotide LAR treatment and for 1 month following the last dose of pasireotide s.c. treatment.

The study is expected to remain open for approximately 10 years or until such time that enrolled patients no longer need treatment with pasireotide or are able to obtain commercial supply according to local regulations for their medical condition.

Conditions

Cushing's Disease; Acromegaly; Neuroendocrine Tumors; Pituitary Tumors; Ectopic ACTH Secreting (EAS) Tumors; Dumping Syndrome; Prostate Cancer; Melanoma Negative for bRAF; Melanoma Negative for nRAS

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pasireotide subcutaneous

0.3mg, 0.6mg and 0.9mg. Doses to be taken BID or TID, dependent on parent study guidelines. Cabergoline may be combined in this arm for Cushing's Disease and Acromegaly patients.

Group Type: EXPERIMENTAL

Pasireotide

Intervention Type: DRUG

Administered subcutaneously in strengths 0.3mg, 0.6mg and 0.9mg. Doses to be taken BID or TID, dependent on parent study guidelines.

Cabergoline

Intervention Type: DRUG

Cabergoline tablet 0.5mg or 1.0mg taken by mouth once daily may be combined with subcutaneous formulation of pasireotide for Cushing's Disease or Acromegaly. Dose is dependent on parent study guidelines.

Pasireotide Long Acting Release (LAR)

10mg, 20mg, 40mg and 60mg. All doses to be taken q28days. Strength is dependent on parent study guidelines.

Group Type: EXPERIMENTAL

Pasireotide LAR

Intervention Type: DRUG

Long Acting Release is administered by a single intramuscular (i.m.) monthly injection. The strengths are 10mg, 20mg, 40mg and 60mg. All doses to be taken q28days. Strength is dependent on parent study guidelines.

Interventions

Pasireotide

Administered subcutaneously in strengths 0.3mg, 0.6mg and 0.9mg. Doses to be taken BID or TID, dependent on parent study guidelines.

Intervention Type: DRUG

Cabergoline

Cabergoline tablet 0.5mg or 1.0mg taken by mouth once daily may be combined with subcutaneous formulation of pasireotide for Cushing's Disease or Acromegaly. Dose is dependent on parent study guidelines.

Intervention Type: DRUG

Pasireotide LAR

Long Acting Release is administered by a single intramuscular (i.m.) monthly injection. The strengths are 10mg, 20mg, 40mg and 60mg. All doses to be taken q28days. Strength is dependent on parent study guidelines.

Intervention Type: DRUG

Other Intervention Names

SOM230; Signifor; dostinex; SOM230; Signifor

Eligibility Criteria

Inclusion Criteria

1. Patient is currently participating in a Novartis-sponsored study receiving pasireotide (LAR and/or s.c.) on monotherapy or combination therapy (for Cushing's Disease or Acromegaly), and has fulfilled all required assessments in the parent study and patients that are benefiting from the study treatment have no other alternatives.

2. Patient is currently benefiting from the treatment with pasireotide, as determined by the investigator

3. Patient has demonstrated compliance, as assessed by the investigator, with the parent study requirements.

4. Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures.

5. Written informed consent obtained prior to enrolling in roll-over study and receiving study medication.

• If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness.

Exclusion Criteria

1. Patient has been permanently discontinued from pasireotide study treatment in the parent study due to unacceptable toxicity, non-compliance to study procedures, withdrawal of consent or any other reason.

2. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.

3. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the study treatment and for 30 days after the final dose of pasireotide s.c. and 84 days after the final dose of pasireotide LAR. Highly effective contraception is defined as either:

• Total abstinence (when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
• Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
• Male sterilization (at least 6 months prior to enrolling). For female patients on the study the vasectomized male partner should be the sole partner for that patient.
• Use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception.
• In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment.
• Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (i.e. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child-bearing potential.
• Sexually active males, unless they use a condom during intercourse while taking drug and for 1 months after pasireotide s.c. last dose and 3 months after pasireotide LAR last dose, should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RECORDATI GROUP

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Recordati

Role: STUDY_DIRECTOR

Recordati AG

Locations

Ximed Research SC - SOM230B2412

La Jolla, California, United States

Cedars Sinai Medical Center Cedars Sinai 4

Los Angeles, California, United States

Stanford Universtiy Medical Center Stanford Hospital & Clinics

Stanford, California, United States

University of Michigan Comprehensive Cancer Center SC-2

Ann Arbor, Michigan, United States

Memorial Sloan-Kettering Cancer Center SC

New York, New York, United States

Virginia Endocrinology Research SC

Chesapeake, Virginia, United States

Swedish Cancer Institute Swedish Cancer Institute (SC)

Seattle, Washington, United States

Recordati Investigative Site

CABA, Buenos Aires, Argentina

Recordati Investigative Site

Mar del Plata, Buenos Aires, Argentina

Recordati Investigative Site

Edegem, Antwerpen, Belgium

Recordati Investigative Site

Bruges, , Belgium

Recordati Investigative Site

Brussels, , Belgium

Recordati Investigative Site

Brussels, , Belgium

Recordati Investigative Site

Ghent, , Belgium

Recordati Investigative Site

Leuven, , Belgium

Recordati Investigative Site

Liège, , Belgium

Recordati Investigative Site

Wilrijk, , Belgium

Recordati Investigative Site

Fortaleza, Ceará, Brazil

Recordati Investigative Site

Curitiba, Paraná, Brazil

Recordati Investigative Site

Rio de Janeiro, Rio de Janeiro, Brazil

Recordati Investigative Site

Porto Alegre, Rio Grande do Sul, Brazil

Recordati Investigative Site

Joinville, Santa Catarina, Brazil

Recordati Investigative Site

Botucatu, São Paulo, Brazil

Recordati Investigative Site

São Paulo, São Paulo, Brazil

Recordati Investigative Site

Sofia, , Bulgaria

Recordati Investigative Site

Halifax, Nova Scotia, Canada

Recordati Investigative Site

London, Ontario, Canada

Recordati Investigative Site

Montreal, Quebec, Canada

Recordati Investigative Site

Montreal, Quebec, Canada

Recordati Investigative Site

Toulouse, Cedex 9, France

Recordati Investigative Site

Angers, , France

Recordati Investigative Site

Bron, , France

Recordati Investigative Site

Le Kremlin-Bicêtre, , France

Recordati Investigative Site

Lille, , France

Recordati Investigative Site

Marseille, , France

Recordati Investigative Site

Pessac, , France

Recordati Investigative Site

Pierre-Bénite, , France

Recordati Investigative Site

Berlin, , Germany

Recordati Investigative Site

Hamburg, , Germany

Recordati Investigative Site

München, , Germany

Recordati Investigative Site

München, , Germany

Recordati Investigative Site

Tübingen, , Germany

Recordati Investigative Site

Ulm, , Germany

Recordati Investigative Site

Würzburg, , Germany

Recordati Investigative Site

Athens, GR, Greece

Recordati Investigative Site

Budapest, , Hungary

Recordati Investigative Site

Bangalore, Karnataka, India

Recordati Investigative Site

Vellore, Tamil Nadu, India

Recordati Investigative Site

Petah Tikva, , Israel

Recordati Investigative Site

Ancona, AN, Italy

Recordati Investigative Site

Genova, GE, Italy

Milano Investigative Site

Milan, MI, Italy

Recordati Investigative Site

Padua, PD, Italy

Recordati Investigative Site

Roma, RM, Italy

Recordati Investigative Site

Nagoya, Aichi-ken, Japan

Recordati Investigative Site

Maebashi, Gunma, Japan

Recordati Investigative Site

Kobe, Hyōgo, Japan

Recordati Investigative Site

Nankoku, Kochi, Japan

Recordati Investigative Site

Kyoto, Kyoto, Japan

Recordati Investigative Site

Suita, Osaka, Japan

Recordati Investigative Site

Kuala Lumpur, , Malaysia

Recordati Investigative Site

Pulau Pinang, , Malaysia

Recordati Investigative Site

Guadalajara, Jalisco, Mexico

Recordati Investigative Site

Mexico City, Mexico City, Mexico

Recordati Investigative Site

Durango, , Mexico

Recordati Investigative Site

Mexico City, , Mexico

Recordati Investigative Site

Groningen, , Netherlands

Recordati Investigative Site

San Isidro, Lima region, Peru

Recordati Investigative Site

Gdansk, , Poland

Recordati Investigative Site

Poznan, , Poland

Recordati Investigative Site

Warsaw, , Poland

Recordati Investigative Site

Wroclaw, , Poland

Recordati Investigative Site

Porto, , Portugal

Recordati Investigative Site

Bucharest, , Romania

Recordati Investigative Site

Barnaul, , Russia

Recordati Investigative Site

Moscow, , Russia

Recordati Investigative Site

Saint Petersburg, , Russia

Recordati Investigative Site

Tyumen, , Russia

Recordati Investigative Site

Seoul, , South Korea

Recordati Investigative Site

Seoul, , South Korea

Recordati Investigative Site

Alicante, Valencia, Spain

Recordati Investigative Site

Barcelona, , Spain

Recordati Investigative Site

Lausanne, , Switzerland

Recordati Investigative Site

Zurich, , Switzerland

Recordati Investigative Site

Taichung, , Taiwan

Recordati Investigative Site

Bangkok, , Thailand

Recordati Investigative Site

Bangkok, , Thailand

Recordati Investigative Site

Songkhla, , Thailand

Recordati Investigative Site

Istanbul, TUR, Turkey (Türkiye)

Recordati Investigative Site

Ankara, , Turkey (Türkiye)

Recordati Investigative Site

Antalya, , Turkey (Türkiye)

Recordati Investigative Site

Istanbul, , Turkey (Türkiye)

Recordati Investigative Site

Izmir, , Turkey (Türkiye)

Recordati Investigative Site

Kocaeli, , Turkey (Türkiye)

Countries

United States; Argentina; Belgium; Brazil; Bulgaria; Canada; France; Germany; Greece; Hungary; India; Israel; Italy; Japan; Malaysia; Mexico; Netherlands; Peru; Poland; Portugal; Romania; Russia; South Korea; Spain; Switzerland; Taiwan; Thailand; Turkey (Türkiye)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

CSOM230B2412

Identifier Type: -

Identifier Source: org_study_id